Spinal Stabilization Exercise Training in Women With Chronic Constipation

NCT06941103 | Not Yet Recruiting

• 1 other identifier: Spinal Stabilization Exercise
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study was planned to investigate the effects of spinal stabilization exercise training on constipation symptom severity, quality of life, perception of recovery, and spinal stability in women with chronic constipation.

Conditions

Constipation

Keywords

spinal stabilization exercise; quality of life; spinal stability

Outcome Measures

Primary Outcomes (1)

• Constipation Severity Scale (CSI)

  Scale Varma et al. it was developed by to determine individuals' defecation frequency, intensity and difficulty experienced during defecation. Kaya et al. Turkish validity and reliability were conducted by . The scale consists of 16 questions and three sub-areas. These areas are 1. Fecal Obstruction, 2. Large Intestinal Laziness and 3. Pain. The lowest total score that can be obtained from the scale is 0 and the highest is 73. A high score indicates that the symptoms are serious.

  two weeks

Secondary Outcomes (5)

• Spinal Stability Assessment

  two weeks

• Patient Assessment Constipation-Quality of Life Scale (PAC-QOL)

  two weeks

• Bowel diary

  two weeks

• Patient Global Impression of Improvement Scale

  two weeks

• Visual Analog Scale (VAS)

  two weeks

Study Arms (2)

Exercise group

EXPERIMENTAL

Spinal stabilization exercise training and recommendation

Other: Spinal stabilization exercise training and recommendation; Other: Recommendation

Control group

OTHER

Recommendation

Other: Recommendation

Interventions

Spinal stabilization exercise training and recommendation OTHER

Spinal stabilization exercise training will be applied 3 days a week for 8 weeks under the supervision of a specialist physiotherapist. Exercises consist of a 5-10 minute warm-up period, 40 minutes SSET and a 5-10 minute cool-down period. Within the scope of the recommendation, information will be given about the definition of constipation, risk factors, and treatment methods.. A brochure will be prepared to be distributed to individuals regarding these issues.

Exercise group

Recommendation OTHER

Within the scope of the recommendation, information will be given about the definition of constipation, risk factors, and treatment methods.. A brochure will be prepared to be distributed to individuals regarding these issues.

Control group; Exercise group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with chronic functional constipation according to Rome 4 diagnostic criteria
• Those between the ages of 18-65
• Women who volunteer to participate in the study will be included.

You may not qualify if:

• Those who are pregnant or breastfeeding
• Neurological diseases (Parkinson, Multiple Sclerosis, hemiplegia, etc.)
• Undercontrolled systemic/metabolic diseases (hypothyroidism, diabetes mellitus, hypokalemia, hypercalcemia, hypomagnesemia, etc.)
• Malignant diseases
• Accompanying colon or gastrointestinal problems (gastrointestinal bleeding, acute inflammation, etc.)
• Secondary constipation presence of alarm symptoms (new onset constipation, rectal bleeding, involuntary weight loss, nausea, vomiting, fever, anemia or a family history of gastrointestinal malignancy)
• Those who received treatment (exercise, surgery, etc.) for the abdominolumbopelvic region in the last year
• Having a history of colostomy or colectomy
• Those with orthopedic limitations that would affect spinal stabilization exercise training
• Those who do not participate in the treatment program regularly.

Sponsors & Collaborators

• Özel Artı Disleksi Özel Eğitim ve Rehabilitasyon Merkezi: lead

Study Sites (1)

Özel Artı Disleksi Özel Eğitim ve Rehabilitasyon Merkezi

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Constipation

Interventions

Health Planning Guidelines

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Planning; Health Care Economics and Organizations

Central Study Contacts

Saliha Beste Bülbül, Master of Science

CONTACT

+90 5075798377; beste06bulbul@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Spinal stabilization exercise training group will receive exercise sessions and outcome assessments will be performed by a investigator who was blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ankara Yildirim Beyazit University

Model Details: Two groups with a control group (recommendation) and exercise group (recommendation+Spinal stabilization exercise training)

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 23, 2025
• Study Start: May 25, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): November 25, 2026
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)